Instructions for the medical use of the medicinal product

VINRON

Tradename

Vinron, Vinron

International non-proprietary name

Vitamin B 1 + B 6 + B 12 + Lidocaine Hydrochloride, Vitamin B1 _ + B6 _ + B12 _ + Lidocaine Hydrochloride injection ,

Compound

Each 2 ml ampoule contains:

Active substance:

Thiamine hydrochloride 100 mg ,

Pyridoxine hydrochloride 100 mg,

Cyanocobalamin 1 mg,

Lidocaine Hydrochloride 20 mg.

Dosage form

Injection.

Pharmacodynamics

Pharmacotherapeutic Group: vitamin IN 1 and his combinations with vitamin B6 and/or vitamin B12. ATC code: A 11 DB Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and the musculoskeletal system. Vitamin B 1 is called the anti-neuritic vitamin. Its phosphorylated form is thiamine pyrophosphate. (DFT) governs split carbohydrates as a carboxylase cofactor and is used in metabolic acidosis.

Vitamin B6 regulates the breakdown of proteins, fats and carbohydrates. Vitamin B12 is essential for cellular metabolism, red blood cell development, and nervous system function. Vitamin AT

12 is a catalyst for the synthesis of nucleic acids and, therefore,

construction of new cell nuclei.

Lidocaine hydrochloride added for relief post-procedural pain.

Pharmacokinetics

Daily need is near one mg thiamine. Excess thiamine is excreted in the urine. Activity detection CCI-dependent enzyme - transketolase - used for determining status B1. Plasma concentration is 2-4 mcg/100 ml. pyridoxine, pyridoxal and pyridoxamine are phosphorylated and oxidized to pyridoxal-5 phosphate ( PALP ). Main inferred metabolite is 4-pyridoxic acid. tryptophan test fits for definitions B6 . In adults, the mean serum PALP value is 1.2 µg/100 ml.

The daily requirement for vitamin B12 is 1 mcg. With food, an average of 1.5-3.5 micrograms of vitamin B12 is absorbed.

Normal plasma vitamin B12 concentration is 200-900 mcg/ml, meaning below 200 mcg/ml regarded like a deficit. Circulating vitamin B12 _ corresponds about 0.1% from general quantity vitamin A.

An intramuscular injection of 200 mg of 10% lidocaine has been reported to produce a serum concentration of 1.3–1.9 µg/mL.

Lidocaine is rapidly metabolized in the liver, and the metabolites and unchanged drug are excreted by the kidneys. Although unchanged lidocaine is excreted in the urine, this is a minor route of excretion, on the which the account for less eleven%. Lidocaine has an initial period half-life.

7-30 minutes and a terminal half-life of 1.5-2 hours.

Indications for use

Adults and children over 12 years old

Treatment of hematological and neurological symptoms caused by permanent deficiency of vitamins B 1, B 6 and B 12.

Contraindications

•       increased sensitivity to active substances or to anyone from auxiliary substances.

•       Application drug not recommended at severe violations cardiac conductivity and acute decompensation broken heart insufficiency.

•       Due to the content of benzyl alcohol, the drug should not be prescribed newborn, especially premature children.

•       Medicinal means it is forbidden apply in pregnancy time and feeding breast.

Special instructions and precautions

limits reception - 90 mg and more benzyl alcohol in day: in children under 3 years of age, the development of toxic and anaphylactoid reactions.

Solution for injections should enter only intramuscularly (in / m), a not intravenously (in / in), to to avoid side effects effects co sides cardiovascular systems. cardiovascular symptoms (arrhythmias, bradycardia).

Use during pregnancy and during breastfeeding

Safe daily dose of vitamin B6 during pregnancy and lactation breastfeeding is before 25 mg. Because the vitamin content AT 6 in this medicinal means is 100 mg in one 2 ml ampoule, his it is forbidden apply in time pregnancy and feeding breast.

Side effect

Immune system disorders:

Rare: hypersensitivity reactions (eg, skin rash, respiratory depression, shock, angioedema).

Benzyl alcohol: hypersensitivity reactions.

Nervous system disorders:

Frequency unknown: dizziness, clouding of consciousness.

Cardiac disorders: Very rare: tachycardia.

Frequency unknown: bradycardia, arrhythmia. Gastrointestinal disorders: Not known: vomiting.

From the side of the skin and subcutaneous tissue: Very rarely: strong sweating, acne, skin reactions With itching and hives.

Musculoskeletal and connective tissue disorders:

Not known: convulsions.

General disorders and reactions at the injection site:

Frequency unknown: systemic reactions, including excitation and/or depression of the central nervous system (balance disturbance, nervousness, sense of danger, euphoria, confusion, dizziness, stupefaction consciousness, tinnitus, blurred or double vision, vomiting, feeling

cold or heat, numbness) may result from rapid administration (inadvertent intravenous administration, injection into well-perfused tissues) or overdose.

Reporting Suspected Adverse Reactions

It is important to report suspected adverse reactions after drug registration. This allows continuous monitoring of the benefit/risk ratio of the medicinal product. medical workers ask inform about any suspects side effects reactions through:

[To be completed at the national level].

Influence on the ability to rule by car and work with mechanisms

Vitamin B 1 + B 6 + B 12 + Lidocaine hydrochloride Injections have no or negligible effect on the ability to drive and use machines.

Interaction with other medicinal products Thiamine is decomposed by solutions containing sulfites. Other vitamins may be inactivated in the presence of vitamin B1 degradation products. Therapeutic doses of vitamin AT 6 may reduce Effect levodopa. Interactions occur with isoniazid, D -penicillamine and cycloserine. Side effects from the heart can increase with parenteral administration of lidocaine simultaneously with adrenaline or norepinephrine. Interactions also occur with sulfonamides. In case of overdose of local anesthetics adrenalin or norepinephrine not should be applied at the same time.

Preclinical safety data

When lidocaine is administered to rats, the resulting metabolic product 2,6-xylidine can be mutagenic.